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510(k) Data Aggregation

    K Number
    K172441
    Device Name
    EPIC Extremity Fracture Plate System
    Manufacturer
    EPIC Extremity, LLC
    Date Cleared
    2017-11-06

    (87 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K163226,K153340
    Why did this record match?
    Reference Devices :

    K163226

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EPIC Extremity Fracture Plate System is indication of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. The plates/screws are intended for single use only.

    Device Description

    The EPIC Extremity Fracture Plate System consists of multiple plate families of various anatomical sizes and shapes, 4.0mm locking and non-locking screws that mate into the plates, 4.0mm fully and partial threaded cancellous bone screws as well as various instruments to assist in implanting the system.

    The EPIC Extremity Fracture Plate System is also designed to accept the 2.7mm/3.5mm locking/non-locking screws and various instruments to assist in implanting the system from the previously cleared EPIC Extremity Plate System (K153340).

    AI/ML Overview

    Based on the provided text, the document is a 510(k) premarket notification for the "EPIC Extremity Fracture Plate System." This submission is for a medical device (bone fixation plates and screws), not an AI/Software as a Medical Device (SaMD). Therefore, the acceptance criteria and study design elements typically associated with AI/SaMD (such as performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

    The document explicitly states:

    • "No clinical testing was required." This means there was no human clinical study conducted for this device.
    • The non-clinical performance data summarized refers to "ASTM F-543," which is a standard specification for metallic medical bone screws. This concerns the mechanical properties and performance of the physical screws, not an AI algorithm's diagnostic or predictive capabilities.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI device meets those criteria using the provided text. The provided document concerns a physical orthopedic implant, not a software-based medical device that would involve AI performance metrics.

    In summary, none of the requested information regarding AI/SaMD acceptance criteria and study details can be extracted from this document, as it is irrelevant to the type of device being discussed.

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